Service Background

CTI Pharma and Medical Services performs identification tests for newly-established cell lines/strains, master cell banks (MCBs), working cell banks (WCBs), and end-of-production cells (EOPCs) in accordance with the requirements of pharmacopoeias and regulatory guidelines of various countries to confirm the source of the cells and whether there is cross-contamination with other cells.

Identification method

1、Isozyme analysis
Isozyme analysis can identify the species of cells. PAGE gel detection is performed on the isozymes of lactate dehydrogenase, 6-phosphate glucose dehydrogenase, nucleoside phosphatase and malate dehydrogenase of the cell line to be tested, and the species of the cell line and the presence of cross contamination are determined by comparing with indicator cells.

2、Chromosome examination and karyotype analysis
Chromosome karyotype analysis can be used to identify the species of cells. New human diploid cell lines and cell banks used for biopharmaceutical production must undergo chromosome examination. Genetically modified human diploid cells are examined in accordance with new human diploid cell lines.

3、PCR
The PCR can identify the species of cells. The conserved genes cytochrome b (CYTB) and cytochrome c oxidase 1 (CO1) have large differences between different species and are used to determine the species.

4、Genetic stability test of recombinant cells
Restriction endonuclease map is used to detect the insertion site; mRNA/cDNA is sequenced to detect the sequence of the inserted fragment; qPCR method is used to detect the gene copy number.

5、Short tandem repeat analysis :STR method
STR can be used to identify cells within a species. The STR loci of cells from different individuals are polymorphic, which can be used to distinguish cells from different individuals of the same species.

6、Flow cytometry
Flow cytometry can be used to identify the unique characteristics of cells. This method can be used to identify recombinant cells, stem cells, etc.

7、Immunofluorescence
Immunofluorescence can be used to identify cells of some species and identify the unique characteristics of cells.

8、Cell morphology identification
The origin of the cell line can be simply determined by observing the growth morphology of adherent cells.

Service process